Cannula system with sterile connector, blood pump, and patient harness

ABSTRACT

A system for assisting a patient&#39;s heart has a pump, an oxygenator, a holder having a pump receiving portion for removably receiving the pump and an oxygenator receiving portion for removably receiving the oxygenator, and a harness configured to surround at least a portion of a patient&#39;s torso. The holder is connected to the harness. The system further has a brace connected to at least a portion of the harness. The brace is configured to extend behind a back portion of a user&#39;s head and to support tubing connected to at least one of the pump and the oxygenator. A priming tray and wet-to-wet connector connecting the cardiac assist system to the cannula so are also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is the United States national phase of InternationalApplication No. PCT/US2016/025264 filed Mar. 31, 2016 and entitled“Cannula System with Sterile Connector, Blood Pump, and PatientHarness”, and claims priority to U.S. Provisional Application No.62/140,778, filed on Mar. 31, 2015 and entitled “Cannula System withSterile Connector, Blood Pump, and Patient Harness”, the disclosure ofwhich is incorporated by reference herein in its entirety.

BACKGROUND OF THE INVENTION Field of the Invention

The disclosure relates to a system for assisting a patient's heartincluding a pump and oxygenator for introducing oxygenated blood to thepulmonary artery of a patient and, in particular, to a holder andharness for mounting the system to the patient.

Description of Related Art

Current therapy for circulatory support for oxygen infusion into apatient's blood may involve a number of adverse events that limit thetherapy's application. These adverse situations include infection,inflammation, fluid build-up in the lungs, the possibilities of strokeand internal bleeding, and device/vein blockage that reduces flow in thesupport system and thus severely affects patients. The interface ofblood with artificial materials can cause thrombus (clotting), which ismanaged by anti-coagulation, which can give rise to internal bleeding.If anti-coagulation is insufficient, clots that develop in theartificial devices can release and flow into the body and generatestrokes. The contact of blood with artificial materials can causeinflammation and infection, even though the materials used are tested tobe biocompatible.

Historically, left and/or right ventricular assist devices (LVAD and/orRVAD) have been used for patients requiring surgical interventionwithout a percutaneous or cath lab option available. These surgicalLVADs and/or RVADs have been used for patients with myocardialinfarction, acute ischemic events (with large left and rightpropagation), cardiogenic shock, LVAD created right ventricular (RV)dysfunction, post-transplant RV failure, and pulmonary hypertension.Acute myocardial infarction and cardiogenic shock have been treated withintraaortic balloon pumps (IABPs) and maximal inotropic support, towhich many patients become refractory. Surgically implanted LVADs cancreate a significant septal shift that leads to a dynamic change in theStarling curve that abruptly places patients into severe RV failure.Patients bridged to transplant from an LVAD with severe RV failure, canbe limited in post-transplant survival. Secondary pulmonary hypertensionleads to an exacerbation of RV failure in acute and chronic situations,which are commonly treated with LVADs.

The current TandemHeart PTVA cardiac assist system manufactured byCardiac Assist, Inc. is a percutaneous left ventricular assist systemhaving a centrifugal pump, a 21 Fr, approximately 65 cm long uptakecannula designed to be placed across the interatrial septum using astandard transseptal puncture technique, and a 15 or 17 Fr returncannula; with the cannulae connected to the pump using standard ⅜ inchsurgical tubing. Systemic flow rates of 3.5-4.0 Liters/Min can beachieved. The TandemHeart device has been studied on acute cardiogenicshock patients and was found to confer a significant hemodynamic benefitcompared to IABPs. It is approved by the FDA for temporary (<6 hr) leftventricular mechanical circulatory support. The TandemHeart system canalso be used in connection with an oxygenator for providingextracorporeal membrane oxygenation, often referred to as ECMO, whichcan be done in veno-arterial configuration to support cardiac andrespiratory function or veno-venous configuration to support justrespiratory function. The TandemHeart system can also be used withcardiac assist systems that pump oxygenated blood received from the leftatrium through a transseptal cannula and return the blood to thearterial system as disclosed, for example, in U.S. Pat. No. 6,808,508 toZafirelis, et al., which is incorporated by reference herein in itsentirety.

At present, the cardiac assist system can be attached to a patient by abelt or strap. Elements of the cardiac assist system can also be held bybeing mounted to stationary objects, such as IV poles, stands, and thelike. However, improved mounting systems that increase patient mobilityand reduce the length of connecting tubing are desirable.

SUMMARY OF THE INVENTION

In view of the foregoing, it is therefore of great clinical value todevelop systems that reduce the adverse situations noted above. It isdesirable to develop a system with a minimal amount of artificialmaterial, that enables a smoothest path of flow so as to minimize bloodflow disturbance, and allows the patient to be mobile, potentially evenwalking, all while flowing a high quantity of blood so as to providecomplete oxygen source and thus allow flexibility of the treatingphysicians to avoid other alternate sources of oxygen, such asmechanical ventilators, which are known to cause lung fiber damage.There is also a need for improved systems for assisting a patient'sheart including a pump and oxygenator for introducing oxygenated bloodto the pulmonary artery of a patient and, in particular, to a holder andharness for mounting the system to the patient. There is an additionalneed for a fast-priming mechanism for priming a pump and/or oxygenatorvery quickly to reduce the patient degradation during extended set uptime for typical systems. There is a further need for a connector thatcan be quickly and easily connected and disconnected, as typical systemsare not easily connected and disconnected and thus are more difficult toprime and to change components when complications occur. Systemsconfigured to address these issues are discussed herein.

According to one aspect of the disclosure, a system for assisting apatient's heart may include a pump; an oxygenator; a holder having apump receiving portion for removably receiving the pump and anoxygenator receiving portion for removably receiving the oxygenator; aharness configured to surround at least a portion of a patient's torso,with the holder being connected to the harness; and a brace connected toat least a portion of the harness. The brace may be configured to extendbehind a back portion of a user's head and to support tubing connectedto at least one of the pump and the oxygenator.

According to other aspects of the present disclosure, the brace may havean attachment portion for connecting the brace to the harness. Theattachment portion may be removably connected to the harness by one ormore fastening elements. The brace may have a support portion extendingfrom the attachment portion for supporting the tubing. The brace has oneor more tubing clips for securing the tubing. The holder may have atleast one connection member for releasably connecting the pump and theoxygenator to the holder. The pump receiving portion may have a flatsurface shaped to engage a base of the pump and one or more tabs forreleasably engaging an outer surface of the pump. The oxygenatorreceiving portion may be shaped to receive a cylindrically-shapedoxygenator. The holder may have a first attachment member and theharness has a second attachment member for removably connecting theholder to the harness. The harness may have one or more sections thatare adjustable in size to conform to a patient's body. The harness mayhave a central opening for placing the harness over a user's head. Theharness may have a connection member for securing the harness to apatient's body. The connection member may be a hook and loop fastener.The tubing may have an inlet tube connected to an inlet of the pump, anoutlet tube connected to an outlet tube, and a connection tube connectedbetween an outlet of the pump and an inlet of the oxygenator. At leastone of the inlet tube, the outlet tube, and the connection tube may beconnected to the brace by one or more tubing clips.

According to other aspects of the present disclosure, a system forassisting a patient's heart may include a pump; an oxygenator; a tubinghaving an inlet tube connected to an inlet of the pump, an outlet tubeconnected to an outlet tube, and a connection tube connected between anoutlet of the pump and an inlet of the oxygenator; a holder having apump receiving portion for removably receiving the pump and anoxygenator receiving portion for removably receiving the oxygenator; aharness configured to surround at least a portion of a patient's torso,the holder being connected to the harness; and a brace connected to atleast a portion of the harness, the brace configured to extend behind aback portion of a user's head and to support tubing connected to atleast one of the pump and the oxygenator, wherein the brace has anattachment portion for connecting the brace to the harness and a supportportion extending from the attachment portion for supporting the tubing.The pump receiving portion has a flat surface shaped to engage a base ofthe pump and one or more tabs for releasably engaging an outer surfaceof the pump. The oxygenator receiving portion is shaped to receive acylindrically-shaped oxygenator. The holder has a first attachmentmember and the harness has a second attachment member for removablyconnecting the holder to the harness

According to other aspects of the present disclosure, a patient harnessfor supporting a system for assisting a patient's heart may include aholder having a pump receiving portion configured for removablyreceiving a pump and an oxygenator receiving portion configured forremovably receiving an oxygenator; a harness configured to surround atleast a portion of a patient's torso, the holder being connected to theharness; and a brace connected to at least a portion of the harness, thebrace configured to extend behind a back portion of a user's head and tosupport tubing connected to at least one of the pump and the oxygenator,wherein the brace has an attachment portion for connecting the brace tothe harness and a support portion extending from the attachment portionfor supporting the tubing.

According to another aspect of the disclosure, a priming tray forpriming a pump and/or oxygenator of a cardiac assist system includes acontainer defining an interior reservoir. The container includes aninlet port and an outlet port. Each port is covered by a self-sealingvalve connector that permits an open end of connecting tubing to beinserted therethrough and which automatically reseals when the end ofthe connecting tubing is removed from the valve connector.

According to another aspect of the disclosure, a connector for primingand establishing a fluid connection between connecting tubing and acannula is provided. The connector includes a housing having a firstport in fluid connection with a cannula and a second port configured tobe removably connected to the connecting tubing. The housing can furtherinclude a port for introducing fluid to the interior of the housingand/or for permitting trapped air to escape from the interior of thehousing. The port can be covered by a hydrophobic filter, a one-wayvalve, or a ball valve. The port can also be covered by a piercableseptum for allowing a syringe to be connected thereto for expellingfluid to the housing or for drawing trapped air from the interior of thehousing.

Various other aspects of the disclosure are further described in one ormore of the following clauses:

Clause 1: A system for assisting a patient's heart, the systemcomprising:

-   -   a pump;    -   an oxygenator;    -   a holder having a pump receiving portion for removably receiving        the pump and an oxygenator receiving portion for removably        receiving the oxygenator;    -   a harness configured to surround at least a portion of a        patient's torso, the holder being connected to the harness; and    -   a brace connected to at least a portion of the harness, the        brace configured to extend behind a back portion of a user's        head and to support tubing connected to at least one of the pump        and the oxygenator.

Clause 2: The system of clause 1, wherein the brace has an attachmentportion for connecting the brace to the harness.

Clause 3: The system of clause 2, wherein the attachment portion isremovably connected to the harness by one or more fastening elements.

Clause 4: The system of any of clauses 1-3, wherein the brace has asupport portion extending from the attachment portion for supporting thetubing.

Clause 5: The system of any of clauses 1-4, wherein the brace has one ormore tubing clips for securing the tubing.

Clause 6: The system of any of clauses 1-5, wherein the holder has atleast one connection member for releasably connecting the pump and theoxygenator to the holder.

Clause 7: The system of any of clauses 1-6, wherein the pump receivingportion has a flat surface shaped to engage a base of the pump and oneor more tabs for releasably engaging an outer surface of the pump.

Clause 8: The system of any of clauses 1-7, wherein the oxygenatorreceiving portion is shaped to receive a cylindrically-shapedoxygenator.

Clause 9: The system of any of clauses 1-8, wherein the holder has afirst attachment member and the harness has a second attachment memberfor removably connecting the holder to the harness.

Clause 10: The system of any of clauses 1-9, wherein the harness has oneor more sections that are adjustable in size to conform to a patient'sbody.

Clause 11: The system of any of clauses 1-10, wherein the harness has acentral opening for placing the harness over a user's head.

Clause 12: The system of any of clauses 1-11, wherein the harness has aconnection member for securing the harness to a patient's body.

Clause 13: The system of clause 12, wherein the connection member is ahook and loop fastener.

Clause 14: The system of any of clauses 1-13, wherein the tubing has aninlet tube connected to an inlet of the pump, an outlet tube connectedto an outlet tube, and a connection tube connected between an outlet ofthe pump and an inlet of the oxygenator.

Clause 15: The system of clause 14, wherein at least one of the inlettube, the outlet tube, and the connection tube are connected to thebrace by one or more tubing clips.

Clause 16: A system for assisting a patient's heart, the systemcomprising:

-   -   a pump;    -   an oxygenator;    -   a tubing having an inlet tube connected to an inlet of the pump,        an outlet tube connected to an outlet tube, and a connection        tube connected between an outlet of the pump and an inlet of the        oxygenator;    -   a holder having a pump receiving portion for removably receiving        the pump and an oxygenator receiving portion for removably        receiving the oxygenator;    -   a harness configured to surround at least a portion of a        patient's torso, the holder being connected to the harness; and    -   a brace connected to at least a portion of the harness, the        brace configured to extend behind a back portion of a user's        head and to support tubing connected to at least one of the pump        and the oxygenator,    -   wherein the brace has an attachment portion for connecting the        brace to the harness and a support portion extending from the        attachment portion for supporting the tubing.

Clause 17: The system of clause 16, wherein the pump receiving portionhas a flat surface shaped to engage a base of the pump and one or moretabs for releasably engaging an outer surface of the pump.

Clause 18: The system of clause 16 or clause 17, wherein the oxygenatorreceiving portion is shaped to receive a cylindrically-shapedoxygenator.

Clause 19: The system of any of clauses 16-18, wherein the holder has afirst attachment member and the harness has a second attachment memberfor removably connecting the holder to the harness.

Clause 20: A patient harness for supporting a system for assisting apatient's heart, the harness comprising:

-   -   a holder having a pump receiving portion configured for        removably receiving a pump and an oxygenator receiving portion        configured for removably receiving an oxygenator;    -   a harness configured to surround at least a portion of a        patient's torso, the holder being connected to the harness; and    -   a brace connected to at least a portion of the harness, the        brace configured to extend behind a back portion of a user's        head and to support tubing connected to at least one of the pump        and the oxygenator,    -   wherein the brace has an attachment portion for connecting the        brace to the harness and a support portion extending from the        attachment portion for supporting the tubing.

BRIEF DESCRIPTION OF THE DRAWINGS

Some of the advantages and features of the preferred aspects orembodiments have been summarized hereinabove. These aspects orembodiments, along with other potential aspects or embodiments willbecome apparent to those skilled in the art when referencing thefollowing drawings in conjunction with the detailed descriptions as theyrelate to the figures.

FIG. 1 is a schematic drawing of a cardiac assist system according to anaspect of the disclosure;

FIG. 2 is a top perspective view of a cardiac assist system includingpump, oxygenator, and holder according to an aspect of the disclosure;

FIG. 3 is a perspective view of a harness for the cardiac assist systemof FIG. 2, according to an aspect of the disclosure;

FIG. 4 is a perspective view of a priming tray connected to the cardiacassist system of FIG. 2, according to an aspect of the disclosure;

FIG. 5A is a perspective view of another aspect of a priming tray in astanding position;

FIG. 5B is a perspective view of the tray of FIG. 5A in a titledposition;

FIG. 6A is a perspective view of another aspect of a priming tray in thestanding position:

FIG. 6B is a perspective view of the tray of FIG. 6A in the tiltedposition;

FIG. 6C is a perspective view of another aspect of a priming tray havinga lid;

FIG. 7A is a perspective view of an inner portion of the valve connectorof the tray of FIG. 4;

FIG. 7B is a perspective view of the outer portion of the valveconnector of the tray of FIG. 4;

FIG. 7C is a perspective view the outer portion of the valve connectorof the tray of FIG. 4 with the connecting tubing removed therefrom;

FIG. 8A is a schematic drawing of a quick release wet-to-wet connectorfor introducing saline to a fluid line in a closed position, accordingto an aspect of the disclosure;

FIG. 8B is a schematic drawing of the quick release connector of FIG. 8Ain an open position;

FIGS. 9A and 9B are schematic drawings of a submersed componentconnector for forming a wet-to-wet connection between portions oftubing, according to another aspect of the disclosure;

FIG. 10 is a schematic drawing of another aspect of a wet-to-wet tubingconnector, according to an aspect of the disclosure;

FIGS. 11A and 11B are schematic drawings of a tubing connector includinga integral hydrophobic membrane, according to an aspect of thedisclosure;

FIGS. 12A and 12B are schematic drawings of another embodiment of atubing connector with an overlapping tubing design, according to anaspect of the disclosure;

FIG. 13A is a schematic drawing of another embodiment of a tubingconnector according to an aspect of the disclosure;

FIG. 13B is a schematic drawing of another embodiment of a tubingconnector, according to an aspect of the disclosure; and

FIGS. 14A and 14B are schematic drawings of an embodiment of a tubingconnector including an automated saline fill mechanism, according to anaspect of the disclosure.

DESCRIPTION OF THE INVENTION

For purposes of the description hereinafter, the terms “upper”, “lower”,“right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”,“longitudinal”, and derivatives thereof shall relate to the componentsas they are oriented in the drawing figures. When used in relation to ablood pump, oxygenator, cannula, connector, and any other component of acardiac assist system, the term “distal” refers to a portion of a bloodpump, oxygenator, cannula, and/or connector, nearest to a patient, suchas an intended access site on the patient's body, when a blood pump,oxygenator, cannula, and/or connector, is oriented for connecting to apatient. The term “proximal” refers to a portion of a blood pump,oxygenator, cannula, and/or connector farthest away from a patient, suchas an intended access site on the patient's body, when a blood pump,oxygenator, cannula, and/or connector is oriented for connecting to apatient. The term “radial” refers to a direction in a cross-sectionalplane normal to a longitudinal axis of a blood pump, oxygenator,cannula, and/or connector extending between proximal and distal ends.The term “circumferential” refers to a direction around an inner orouter surface of a blood pump, oxygenator, cannula, and/or connector.The term “axial” refers to a direction along a longitudinal axis of ablood pump, oxygenator, cannula, and/or connector extending between theproximal and distal ends. It is to be understood, however, that thedisclosure may assume alternative variations and step sequences, exceptwhere expressly specified to the contrary. It is also to be understoodthat the specific devices and processes illustrated in the attacheddrawings, and described in the following specification, are simplyexemplary aspects of the disclosure. Hence, specific dimensions andother physical characteristics related to the aspects disclosed hereinare not to be considered as limiting.

The following description is provided to enable those skilled in the artto make and use the described embodiments contemplated for carrying outthe invention. Various modifications, equivalents, variations, andalternatives, however, will remain readily apparent to those skilled inthe art. Any and all such modifications, variations, equivalents, andalternatives are intended to fall within the spirit and scope of thepresent invention.

Cardiac Assist System

With reference to FIG. 1, a system 10 for cardiac assistance of apatient's heart 2, such as for bypassing the left and/or right ventricleto provide oxygenated blood to the arterial system via the femoral,axillary, or the pulmonary artery, is illustrated. A cardiac assistsystem, which can be adapted for use with the holders, harnesses,connectors, and priming apparatus of the present disclosure, isgenerally disclosed in U.S. Pat. No. 8,550,973 to Magovern et al., whichis incorporated by reference in its entirety. Another right heart assistsystem and a method of applying the system to a patient are disclosed inU.S. Pat. No. 8,562,519 to Smith et al., which is also incorporated byreference herein. Another cardiac assist system is disclosed in U.S.Pat. No. 6,808,508 to Zafirelis, et al., which is discussed hereinaboveand also incorporated by reference herein.

The system 10, as shown in FIG. 1, includes a drainage cannula 12 thatis adapted to extend from the right atrium of the heart in fluidcommunication with a pump 14 to provide blood to the pump 14. The system10 also includes a femoral or pulmonary artery cannula 16. In someaspects, the cannula 16 can be at least 17 cm in length when configuredfor insertion into the femoral artery and at least 70 cm in length whenconfigured for insertion into the pulmonary artery, and adapted toextend from the patient's groin to the pulmonary artery of the patientto provide blood to the pulmonary artery for right ventricular support.The cannula 16 can be a dual lumen cannula in the internal jugular vein,a surgical cannula connected directly to the heart, and, as will bediscussed herein, can be connected with or without an oxygenator. Thecannula 16 can be a steerable cannula with a steerable mechanism tocontrol the position and shape of the cannula body. Further, the cannula16 can have a balloon tip to enable self-direction and placement into aflow-directed vessel. An additional lumen can enable placement ofadditional wires or clot removal devices into the pulmonary artery orvessel. Further, if the cannula 16 is a dual lumen cannula, thetransition taper between the side holes on the cannula body can havecut-outs to enable strain relief during placement or manipulation orcurving of the cannula around a tortuous anatomy. Finally, a coating onthe tip of the cannula 16 can enable radiopacity for placement andposition determination. In some aspects, the cannula 16 can be thecannula described in U.S. Pat. No. 9,168,352 to Kelly et al.

The pulmonary artery cannula 16 is in fluid communication with the pump14, whereby the heart's right ventricle is essentially bypassed bydraining the right atrium and pumping blood into the pulmonary arterythereby allowing the right ventricle of the patient to rest and enableright ventricular support. Preferably, the pump 14 is a ventricularassist pump, such as a centrifugal, axial, mixed, or roller pump, as isknown in the art, that produces adequate flow rates through the system10 to achieve desired therapeutic results (e.g., either cardiac assistor right ventricular bypass). A suitable pump 14 for use with theabove-described system 10 is disclosed in U.S. Pat. No. 6,808,508 toZafirelis et al.

The system 10 can also include an oxygenator 18 in fluid communicationwith the pump 14. The oxygenator 18 receives blood pumped by the pump14, oxygenates the blood, and through the pulmonary artery cannula 16,provides oxygenated blood to the pulmonary artery. The oxygenator 18 canbe a spiral wound sheet membrane type oxygenator or any of the hollowfiber membrane type oxygenators including, but not limited to, theCAPIOX® oxygenator manufactured by the Terumo Cardiovascular Group,MINIMAX® or AFINITY® oxygenator manufactured by Medtronic, QUADROX®oxygenator manufactured by Maquet, Gish Vision oxygenator manufacturedby Gish Biomedical, Cobe Optima oxygenator, and others. A controllerthat may be used for the pump and oxygenator is described in U.S. Pat.No. 6,808,508 to Zafirelis et al.

In some aspects, the system 10 can be applied to a patient according tothe following method. The method includes inserting a tip of thepulmonary artery cannula 16 into a right femoral vein of a patient, andmoving the tip through the right femoral vein until side holes of thecannula 16 in proximity to the tip are disposed in the pulmonary artery.Then, the drainage cannula 12 is inserted into the patient'svasculature, and moved through the patient's vasculature until the tipof the drainage cannula 12 is disposed in the right atrium. Then, aninlet of the pump 14 is connected to the drainage cannula 12 with inletconnecting tubing 20. Similarly, the pulmonary artery cannula 16 isconnected to an outlet of the oxygenator 18 through outlet connectingtubing 22. Another piece of auxiliary connecting tubing 24 is connectedbetween the outlet of the pump 14 and the inlet of the oxygenator 18 toform a circuit. Finally, the pump 14 and the oxygenator 18 secured tothe patient. In operation, blood received by the pump 14 from thedrainage cannula 12 is pumped to the pulmonary artery through thepulmonary artery cannula 16 to provide right ventricular and respiratorysupport without having to bypass the heart and lungs.

Holder and Harness

Having generally described the cardiac assist system 10, devices formounting elements of the system 10 together and for securing the system10 to the patient will now be discussed in detail. With reference toFIG. 2, the system 10 includes a holder 26 which holds the blood pump 14and oxygenator 18 in place and, in particular, enables a compactconnection between the oxygenator 18 and pump 14 in an easilymaneuverable package that can be assembled and primed by a singleoperator. The holder 26 is formed from a suitable rigid material capableof supporting the pump 14 and oxygenator 18 such as high densitypolyethylene, polystyrene, or other known biocompatible polymermaterials, and can include flexible portions such as tabs, protrusions,or snaps for attaching or connecting the pump 14 and oxygenator 18 tothe holder 26. More specifically, the holder 26 includes a pumpreceiving portion 28 configured to receive the pump 14, which caninclude a plurality of tabs 30 or snaps for engaging the pump 14 to theholder 26. For example, the pump receiving portion 28 can include a flatsurface sized and shaped to receive a base of the pump 14 and one ormore tabs 30 extending therefrom for grasping the sides of the pump 14to hold it in place. The holder 26 also includes an oxygenator receivingportion 32 sized and shaped to receive the cylindrical body of theoxygenator 18. The holder 26 also includes a mechanism, such as a tab orflexible protrusion 19, extending from the holder for connecting theholder 26 to a corresponding structure on the patient such as aconnector on a vest, belt, or arm band, as described herein.

One feature of the holder 26 is that by integrating the pump 14 andoxygenator 18, as shown in FIG. 2, priming is simplified by eliminatinglong connecting tubing and connectors between elements of the system 10.In addition, the pump 14 is positioned and effectively held in place toreduce strain on tubing that can contribute to tubing leaks, kinks intubing, and similar problems. Further, the shape of the holder 26 isdesigned to prevent air from entering the patient if an air embolusoccurs. Finally, the oxygenator 18 is positioned so that caps andconnectors, such as the inlet and outlet of the oxygenator 18, areeasily accessible to allow for easy hook-up of tubing and easy removalof condensation build up from the oxygenator 18.

Another feature of the holder 26 is to maintain the position of the pump14 relative to the cannulae 12, 16 (shown in FIG. 1). In particular,since the cannulae 12, 16 are positioned within the patient's body, itis also desirable to maintain the position of the pump 14 relative tothe patient. Mounting the pump 14 to the patient reduces the possibilitythat the cannulae 12, 16 will be inadvertently pulled out of thepatient, or that the cannulae 12, 16 will become disconnected from thepump 14 or the oxygenator 18.

With reference to FIG. 3, a harness 50 for mounting the system 10,including the pump 14, oxygenator 18, and holder 26, to the patient isillustrated. The harness 50 is configured to mount the elements of thesystem 10 to the patient in a manner that increases patient mobility,reduces staffing needs, increases safety, and lowers costs. Inparticular, while wearing the harness 50, the patient is able to walk,lie down, and sit up. The harness 50 includes a vest or sling 52 wornaround the upper torso of the patient. In some aspects, the vest orsling 52 is configured to surround the patient's upper torso around thepatient's shoulders. The vest or sling 52 may be made from one or moresections that are adjustable in size to better conform to the patient'sbody. The vest or sling 52 may be formed from a breathable andbiocompatible material such as cotton, neoprene, polyester, or nylon.The vest or sling 52 also includes an attachment mechanism 58, such as afabric hook and loop fastener (e.g., Velcro®) for securing the harnessor sling 52 to the patient. The holder 26, along with the pump 14 andoxygenator 18 attached thereto, are removably mounted to the vest orsling 52. For example, the tab 19 extending from the holder 26 can beconfigured to be inserted in a slot or receiving portion of the vest orsling 52. Alternatively, or in addition, the vest or sling 52 caninclude straps 54 that wrap around the holder 26 for attaching theholder 26 to the vest or sling 52. In either case, the holder 26 can beremoved from the harness 50 and mounted to a stationary object such as abedrail, bed, table, or IV pole.

In some aspects, the sling or vest 52 can include a central opening 21such that the sling or vest 52 can be placed over the head of thepatient. The over-the-head design enables placement rapidly of the vestor sling 52 on a patient without having to turn or manipulate thepatient's body for implementation. Alternatively, the vest or sling 52may be wrapped around the upper torso of the patient and can include theattachment mechanism 58, such as a strap and/or a clip, for removablyattaching opposing ends of the sling or vest 52 together.

With continued reference to FIG. 3, the connecting tubing 20, 22 ismanaged with a neck brace 60 and tubing clips 62 for connecting thetubing 20, 22 to the brace 60 and to prevent kinking and dislodgement ofthe tubing 20, 22. The neck brace 60 has an attachment portion 61 forconnecting the neck brace 60 to at least a portion of the vest or sling52. One or more fastening elements, such as clips, straps, or othermechanical fastening elements, may be provided to secure the attachmentportion 61 of the neck brace 60 to the vest or sling 52. A supportportion 63 of the neck brace 60 extends from the attachment portion 61and is configured for supporting at least a portion of the connectingtubing 20, 22. The support portion 63 may extend around at least aportion of a back portion of the user's head. One or more tubing clips62 are provided on the support portion 63 for receiving the connectingtubing 20, 22. In use, the neck brace 60 enables increased neck mobilitycompared to other tubing control mechanisms and, in particular, allowsthe patient to turn his or her head across a full range or a substantialrange of motion. While FIG. 3 illustrates the neck brace 60 as acomponent that is attachable to the vest or sling 52 by an attachmentportion 61, the neck brace 60 may be worn separately from the vest orsling 52.

The combination of the harness or sling 52, neck brace 60, and holder 26allows for a small compact circuit on the patient and, in particular,reduces the length of connective tubing 20, 22 needed for connecting thedischarge cannula 12 and pulmonary artery cannula 16 to the patient. Assuch, a heat exchanger is not required for the system disclosed herein,although a heat exchanger can optionally be used with the system.

Priming the System Prior to Use

An important consideration in connecting and using the system 10 of thepresent disclosure is to control and, to the extent possible, reduce thepriming volume and pressure drop through the tubing 20, 22, 24, the pump14, and the oxygenator 18. As discussed above in connection with theharness 50 and the holder 26, it is desirable to secure the pump 14 tothe patient so that the tubing 20, 22, 24 can be maintained as short aspossible, thus minimizing the prime volume, and keeping pressure drop aslow as possible. Limiting pressure drop effectively also maximizes theflow rate through the tubing 20, 22, 24. Thus, if one cannula is in theleg and one is in the neck, it is important to provide a means ofconnecting the two with a circuit as compact as possible. For example,placing the pump 14 adjacent to the upper torso of the patient providesa very short path to one cannula and a longer path to the other cannula.In terms of pressure drops, it is advantageous to minimize the negativepressure drop (very high negative pressure can lead to hemolysis orcavitation in the blood), so it is desirable to locate the pump 14 closeto the cannula which takes blood from the patient's right atrium/SVC(Superior Vena Cava)/IVC (Interior Vena Cava) and carries it to the pump14. The longer tubing run can then be on the outflow side, which is thepositive pressure side of the pump 14.

With regard to priming the pump 14 and oxygenator 18, before the pump 14is attached to the cannula and patient, two chambers (upper and lower)of the pump 14 are primed to prevent air from being pumped into thepatient. The lower chamber uses fluid infusate to provide a bearingfunction to the pump 14 that prevents motor wear, provides cooling, andprovides anti-coagulation directly to the upper chamber, where bloodflows during operation of the pump 14. In some aspects, a syringe can beused to push fluid into the lower chamber of the pump 14. The pump 14 isthen started, with the pumping action pulling all air through the sealseparating the upper and lower chambers. Alternately, a syringe with atwo way stopcock can be used to suck air out of the lower chamber priorto filling the lower chamber with the infusate.

Similarly, the upper chamber, or blood flow chamber, is filled with apriming fluid from either the inflow or outflow port. Owing to the lowpump volume, this can be accomplished with saline solution. For example,prior to using the system 10 to treat a patient, the pump 14 andoxygenator 18 are primed by slowly filling the blood chamber of the pump14 with saline, to remove all air therefrom. Once the air is removed,the tubing 20, 22 can be clamped below the saline line to ensure that aproper wet-to-wet connection is established between the pump 14 inletand the right atrium cannula 12. The user may also check for air bubblesand, if none are present, can finish pushing tubing 20, 22 over thecannula connector to establish a suitable connection therebetween.

Once a suitable connection between the tubing 20, 22 and cannulae 12, 16is established, support can be initiated by turning the pump 14 on atlow speed, releasing the tubing clamps on the inlet side of the pump 14,and checking for air in the outlet side of the pump 14. If there is noair present, the user releases the remaining tubing clamps, and adjuststhe speed until a desired flow rate is achieved.

Priming Tray

Having described the importance of priming the system 10 prior to use,an apparatus for gravity fed priming of the connecting tubing 20, 22 andpump 14 prior to connection to the cannulae 12, 16 will now be discussedin detail. Specifically, with reference to FIGS. 4-7C, a priming tray110 may be configured to introduce a sterile priming fluid, such assaline, to the pump 14, oxygenator 18, and connecting tubing 20, 22. Thepriming tray 110 may be configured as a container including an interiorreservoir 112 for holding a volume of fluid, such as saline. Thecontainer may be constructed from any material suitable for containingthe priming fluid. In some aspects, the priming tray 110 may be madefrom plastic, metal, rubber, and combinations thereof. The priming tray110 includes an inlet port 114 having an inlet valve connector 118 andan outlet port 116 having an outlet valve connector 120. The inlet andoutlet portions 114, 116 extend through a sidewall of the priming tray110 extending substantially vertically above a bottom surface. The inletvalve connector 118 of the inlet port 114 is configured for connectingthe outlet connecting tubing 22 for connection to the oxygenator 18, andthe outlet valve connector 120 of the outlet port 116 is configured forconnecting to the inlet connecting tubing 20 extending to the inlet portof the pump 14 to form a circuit.

The interior reservoir 112 of the priming tray 110 can be tapered orangled towards the outlet port 116 so that the inlet port 114 is at ahigher elevation relative to the outlet port 116 when the priming tray110 is placed on a level surface. In this manner, fluid may be gravityfed from the inlet port 114 to the outlet port 116. In particular, theshape of the interior reservoir 112 of the priming tray 110 is selectedto establish quick and accurate priming driven by gravity. The locationof the inlet and outlet valve connectors 118, 120 is selected to preventair lock and to enable gravity priming of the system 10. As shown inFIGS. 5A and 5B, in some aspects, an exterior 122 of the tray 110includes both a flat base surface 124 and an angled base surface 126. Auser can place the tray 110 in an upright position, in which the tray110 is supported on the flat base surface 124. As shown in FIG. 5B, thetray 110 can also be tilted to rest on the angled surface 126 so thatfluid can more easily drain from the inlet port 114 to the outlet port116. The priming tray 110 enables priming of the pump 14 and/oroxygenator 18 by connecting the inlet and outlet connecting tubing 20,22 of the system 10 to the inlet and outlet valve connectors 118, 120and adding a fluid, such as saline, to the reservoir 112 of the primingtray 110. As a result of the shape of the fluid reservoir 112, fluidflows through the outlet connector 120 of the outflow port 116 bygravity.

With reference to FIGS. 6A and 6B, the priming tray 110 is illustratedin accordance with another aspect. The priming tray 110 includes anupper interior or reservoir 111 and a lower (main) interior or reservoir112. The reservoirs 111, 112 are vertically offset relative to oneanother when the priming tray 110 is placed on a horizontal surface. Thereservoirs 111, 112 are connected by tubing 128 extending from a bottomsurface of the upper reservoir 111 to a sidewall of the main or lowerreservoir 112. In use, fluid introduced to the upper reservoir 111 canflow from the upper reservoir 111 through the tubing 128 and into thelower reservoir 112. Fluid in the lower reservoir 112 can drain throughthe outlet valve connector 120 and inlet connecting tubing 20 to thepump 14. As in the other aspects described herein, the priming tray 110can be placed in an angled position, such as shown in FIG. 6B, toincrease the fluid flow from the priming tray 110.

In some aspects, the size of the interior reservoir 112, pump 114, andoxygenator 118 are chosen such that the pump 114, oxygenator 114, andconnecting tubing 20, 22, 24 can be placed inside the interior reservoir112 of the priming tray 110 during shipping. With reference to FIG. 6C,a removable lid 129 may be provided to enclose at least a portion of theinterior reservoir 112 during shipping. The lid 129 may further be usedduring priming to prevent fluid from splashing outside the interiorreservoir during priming. The entire package can be sterilized to enablea single operator to prime the system 10 without needing others toassist in the sterilization and/or priming activities as is required incurrent systems.

With specific reference to FIGS. 7A-7C, expanded views of the valveconnector 118, 120 between the priming tray 110 and connecting tubing20, 22 are illustrated. As shown in the figures, the valve connector118, 120 can include a valve for creating a suitable seal around theflexible tubing to ensure a good connection without leaks. Inparticular, the shape of the valve connectors 118, 120 is selected toenable priming without spilling fluid during the priming process. Morespecifically, as shown in FIG. 7A, the connecting tubing 20 is insertedthrough the valve connector 118 such that the end of the tubing extendsinto the interior 112 of the priming tray 110. The valve seals aroundthe sidewall of the connecting tubing 20, 22 to prevent leaks. The valveconnector 118, 120 is also configured to automatically reseal when thetubing 20, 22 is removed from the connector 118, 120 to preventspillage. In use, once the system 10 is primed, the connecting tubing20, 22 is removed from the tray 110 and connected to the drainage orpulmonary artery cannulae 12, 16 so that cardiac assistance to thepatient can be provided.

Wet-to-Wet Connector

Having described the cardiac assist system 10 and priming tray 110 forpriming the pump 14 and oxygenator 18, connector 200 for connecting theprimed connecting tubing 20, 22 to the cannulae 12, 16 will now bediscussed in detail. As with the process for priming the pump 14 andoxygenator 18, it is important to remove air from the connector 200 andconnecting tubing 20, 22 prior to connection to the cannulae 12, 16 toform a secure connection.

With reference to FIGS. 8A and 8B, the connector 200 is an automaticallyclosing joint including a hinge 212 and lock mechanism or latch 214 forconnecting two ends of a fluid conduit, such as an end of connectingtubing 20 and a proximal end of a catheter or cannula 12. While FIGS.8A-8B illustrate the connector 200 for connecting the inlet connectingtubing 20 with the drainage cannula 12, it is to be understood that thesame connector 200 can be used for connecting the outlet connectingtubing 22 with the femoral or pulmonary artery cannula 16. The connector200 includes a first portion 200 a connected to the first tubingportion, such as the inlet connecting tubing 20, and a second portion200 b connected to the second tubing portion, such as the femoral orpulmonary artery cannula 16. The first and second portions 200 a, 200 bare hingedly coupled together by the hinge 212. The hinge 212 and/or oneof the first and second portions 200 a, 200 b can include a biasingmember, such as a spring 216, that automatically closes to connect theends of the opposing first and second portions 200 a, 200 b togetherwhen the user releases one of the first portion 200 a or the secondportion 200 b. In particular, as shown in FIGS. 8A and 8B, the connector200 is transitionable from an open position, in which the ends of theconnecting tubing 20 and the cannula 12 are disconnected from oneanother, to a closed position in which the ends of the connecting tubing20 and the cannula 12 are connected together to enable fluid to passtherebetween through the connector 200. Initially, with the connector200 in the open position, the user can introduce saline to theconnecting tubing 20 and the cannula 12 for priming the connector 200.Once the fluid conduits are filled, as shown in FIG. 8B, the user cantransition the connector 200 back to the closed position, such as byreleasing one of the first portion 200 a or the second portion 200 b andallowing the biasing member to bias the connector 200 to a closedposition. Once the connector 200 is filled and in the closed position,fluid communication can be established from the patient to the pump 14through the connector 200 and connecting tubing 20.

The connector 200 can be a one-handed connector that can be grasped by auser with one hand and held in an open position with one hand. When theuser releases the connector 200, the spring 216 exerts a biasing forcewhich returns the connector 200 to the closed position. It is noted thatthe ends of the fluid conduits that are connected together through theconnector 200 may be shaped such that one end is inserted in the end ofthe other fluid connector. For example, the end of one of the firstportion or the second portion 200 a, 200 b can include an outwardlyflared portion 218 that is sized to receive a corresponding taperedportion 220 of the other of the first portion 200 a and the secondportion 200 b, as shown in FIGS. 8A and 8B.

With reference to FIGS. 9A and 9B, in another aspect, the connector 200includes a submersible component having a housing or enclosure 222, withopposing ports for receiving ends of fluid conduits. In some aspects,the housing or enclosure 222 may be formed as a flexible bag. A port 224located on an end of the housing or enclosure 222 can be connected to aproximal end of the cannulae 12, 16. In some aspects, the cannulae 12,16 can be non-removably coupled with the housing or enclosure 222. Aport 226 located on the opposing end of the housing or enclosure 222 canbe configured to removably receive the end of the connecting tubing 20,22 extending from the pump 14 or oxygenator 18. As shown in FIG. 9B, theend of the cannulae 12, 16 can have a tapered nozzle or connector 223,such as a luer connector, for establishing a fluid connection betweenthe cannulae 12, 16 and tubing 20, 22. Other connectors, such asthreaded connectors, snap fit connectors, and the like can also be used.The end of the connecting tubing 20, 22 is inserted through the port 226and into the interior of the housing or enclosure 222 for removablyconnecting with the connector 223 of the cannulae 12, 16. In someembodiments, the connecting tubing 20, 22 can include a radiallyextending flange 228 configured to cover the port 226 to form a suitableseal between the connecting tubing 20, 22 and port 226. The port 226 canalso include an annular rubber wiper 230 for sealing the port 226 toprevent spillage when the connecting tubing 20, 22 is removed from theport 226. In use, the end of the connecting tubing 20, 22 is insertedinto the port 226 to form a seal, but is not connected to the cannulae12, 16. The interior of the bag 222 is then filled with saline to primeor remove air from the connector 200 and connecting tubing 20, 22. Oncethe bag 222 is filled with a sufficient volume of fluid, the end of theconnecting tubing 20, 22 can be pushed toward the end of the cannulae12, 16 to form a suitable connection therebetween.

With reference to FIG. 10, in another embodiment, the connector 200includes a tubular housing 231 shaped like a three-way valve orT-connector. The housing 231 includes a first end or port 224 forreceiving a cannulae 12, 16 and a second end or port 226 sized andshaped to connect with connecting tubing 20, 22 extending from the pump14 or oxygenator 18. The cannula receiving end or port 224 can be fusedto the cannulae 12, 16 or removeably attached thereto. The connectingtubing receiving end or port 226 can include a tapered openingconfigured to engage a male luer connector of the connecting tubing 20,22. Other connectors, such as threaded connectors, snap fit connectors,and the like can also be used. A fluid entry port 232 extends from acentral portion of the connector housing 231. The fluid entry port 232can include a valve, such as a ball valve 234, for selectively openingor closing the fluid entry port 232 to allow air or fluid to passtherethrough. In use, once the connecting tubing 20, 22 and cannulae 12,16 are connected to the housing 231, the ball valve 234 is opened andfluid is introduced through the valve 234. Once a suitable amount offluid to effectively remove air from the system 10 is added, the valve234 can be closed to establish a suitable connection between theconnectors 200 and cannulae 12, 16.

With reference to FIGS. 11A and 11B, another embodiment or aspect of aconnector 200 for introducing fluid into the system 10 using a syringe290 is illustrated. As in previously described embodiments or aspects,the connector 200 includes an elongate tubular housing 231 including afirst port 224 for connection to a cannulae 12, 16 and an opposingsecond port 226 for connection to connecting tubing 20, 22 extendingfrom the pump 14 or oxygenator 18. The elongate tubular housing 231includes a side port or fluid entry port 232 extending from a sidewallthereof and connected to the syringe 290 for introducing a primingfluid, such as saline, to the connector 200. The sidewall of theelongate tubular housing 231 also includes a second opening 236 coveredby a hydrophobic membrane 238. When saline is expelled from the syringe290 and introduced to the connector 200, any trapped air is permitted toescape from the elongate tubular housing 231 through the hydrophobicmembrane 238. Once all air is expelled from the connector, the clamps292 can be released for permitting fluid flow from the connecting tubing20,22, through the connector 200, and to the cannulae 12, 16.

With reference to FIGS. 12A and 12B, in another embodiment, theconnector 200 includes an overlapping tube design for pressing anenlarged proximal end of the cannulae 12, 16 or connecting tubing 20, 22over a corresponding portion of the connector 200. As the cannulae 12,16 and connector 200 are brought together, the volume of the interior ofthe connector 200 is reduced causing any air in the interior of theconnector 200 to be forced out of the connector 200 through a portcovered by the hydrophobic membrane 238.

With reference to FIG. 13A, in another embodiment, the connector 200 andsystem 10 are configured to allow a user to draw air from the connector200 using a syringe 290. As in previously described embodiments, theconnector 200 includes an elongate tubular housing 231 having a firstport 224 and a second port 226 for connection with the cannulae 12, 16and connecting tubing 20, 22, respectively. The connector 200 alsoincludes a resealable port 240 covered by a piercable septum configuredto be pierced by the syringe 290 and a separate port with a one-wayvalve 242 for allowing air to escape from an interior of the connectorhousing 231. In use, the user inserts a full syringe 290 containing apriming fluid, such as saline, through the piercable septum. The userexpels the fluid from the syringe 290 and into the housing 231. Afterthe housing 231 is filled, the filled connector 202 is connected toflexible connecting tubing 20, 22 extending to the pump 14 or oxygenator18. Any air that is trapped in the connector 200 as fluid is beingexpelled into the housing 231 can escape through the port covered by theone-way valve 242.

Alternatively, as shown in FIG. 13B, after the fluid is injected intothe housing 231, the user can insert an empty syringe 290 through thepiercable septum and remove any trapped air from the interior of thehousing 231 by drawing the plunger of the syringe 290 in a proximaldirection through the syringe barrel. Once all air is removed, a clamp292 on the cannula can be removed to establish fluid communicationbetween the pump 14 or oxygenator 18 and the patient through theconnector 200 and cannulae 12, 16.

With reference to FIGS. 14A and 14B, an automated saline fill connector200 is illustrated. As in previously described embodiments, theconnector 200 includes a housing 231 with a first port 224 forconnection to a cannulae 12, 16 and a second port 226 for connection toflexible connecting tubing 20, 22 leading to the pump 14 or oxygenator18. The housing 231 encloses a prefilled saline pressurizedmicro-canister 244. The micro-canister 244 is controlled by a releasebutton 246 extending through the housing 231. As shown in FIG. 14B, thecanister 244 includes a movable cap or piston 248 extending from the topof the canister 244. When the canister 244 is activated by pressing therelease button 246, the cap or piston 248 is moved in an upwarddirection pushing air away from the interior of the connector 230 andtoward a one way valve 242. Once the cap or piston 248 is released,pressurized saline is permitted to flow from the canister 244, throughthe interior of the housing 231, and towards the connecting tubing 20,22 and cannulae 12, 16. As in previously described connectors, once thetubing 20, 22 and pump are primed, a clamp 292 on the cannulae 12, 16can be opened for establishing fluid communication between the pump 14and the patient.

While specific embodiments and aspects have been described in detail inthe foregoing, it will be appreciated by those skilled in the art thatvarious modifications and alternatives to those details could bedeveloped in light of the overall teachings of the disclosure.Accordingly, the particular arrangements disclosed are meant to beillustrative only and not limiting as to the scope of invention.Further, although the invention has been described in detail for thepurpose of illustration based on what is currently considered to be themost practical and preferred embodiments and aspects, it is to beunderstood that such detail is solely for that purpose and that theinvention is not limited to the disclosed embodiments and aspects, but,on the contrary, is intended to cover modifications and equivalentarrangements that are within the spirit and scope of the appendedclaims. For example, it is to be understood that the present inventioncontemplates that, to the extent possible, one or more features of anyembodiment or aspect can be combined with one or more features of anyother embodiment or aspect.

What is claimed is:
 1. A system for assisting a patient's heart, thesystem comprising: a pump; an oxygenator; a holder having a pumpreceiving portion for removably receiving the pump and an oxygenatorreceiving portion for removably receiving the oxygenator; a harnessconfigured to surround at least a portion of a patient's torso, theholder being connected to the harness; and a brace connected to at leasta portion of the harness; the brace configured to extend behind a backportion of a user's head and to support tubing connected to at least oneof the pump and the oxygenator.
 2. The system of claim 1, wherein thebrace has an attachment portion for connecting the brace to the harness.3. The system of claim 2, wherein the attachment portion is removablyconnected to the harness by one or more fastening elements.
 4. Thesystem of claim 2, wherein the brace has a support portion extendingfrom the attachment portion for supporting the tubing.
 5. The system ofclaim 1, wherein the brace has one or more tubing clips for securing thetubing.
 6. The system of claim 1, wherein the holder has at least oneconnection member for releasably connecting the pump and the oxygenatorto the holder.
 7. The system of claim 1, wherein the pump receivingportion has a flat surface shaped to engage a base of the pump and oneor more tabs for releasably engaging an outer surface of the pump. 8.The system of claim 1, wherein the oxygenator receiving portion isshaped to receive a cylindrically-shaped oxygenator.
 9. The system ofclaim 1, wherein the holder has a first attachment member and theharness has a second attachment member for removably connecting theholder to the harness.
 10. The system of claim 1, wherein the harnesshas one or more sections that are adjustable in size to conform to apatient's body.
 11. The system of claim 1, wherein the harness has acentral opening for placing the harness over a user's head.
 12. Thesystem of claim 1, wherein the harness has a connection member forsecuring the harness to a patient's body.
 13. The system of claim 12,wherein the connection member is a hook and loop fastener.
 14. Thesystem of claim 1, wherein the tubing has an inlet tube connected to aninlet of the pump, an outlet tube connected to an outlet of theoxygenator, and a connection tube connected between an outlet of thepump and an inlet of the oxygenator.
 15. The system of claim 14, whereinat least one of the inlet tube, the outlet tube, and the connection tubeare connected to the brace by one or more tubing clips.
 16. A system forassisting a patient's heart, the system comprising: a pump; anoxygenator; a tubing having an inlet tube connected to an inlet of thepump, an outlet tube connected to an outlet of the oxygenator, and aconnection tube connected between an outlet of the pump and an inlet ofthe oxygenator; a holder having a pump receiving portion for removablyreceiving the pump and an oxygenator receiving portion for removablyreceiving the oxygenator; a harness configured to surround at least aportion of a patient's torso, the holder being connected to the harness;and a brace connected to at least a portion of the harness, the braceconfigured to extend behind a back portion of a user's head and tosupport tubing connected to at least one of the pump and the oxygenator,wherein the brace has an attachment portion for connecting the brace tothe harness and a support portion extending from the attachment portionfor supporting the tubing.
 17. The system of claim 16, wherein the pumpreceiving portion has a flat surface shaped to engage a base of the pumpand one or more tabs for releasably engaging an outer surface of thepump.
 18. The system of claim 16, wherein the oxygenator receivingportion is shaped to receive a cylindrically-shaped oxygenator.
 19. Thesystem of claim 1, wherein the holder has a first attachment member andthe harness has a second attachment member for removably connecting theholder to the harness.
 20. A patient harness for supporting a system forassisting a patient's heart, the harness comprising: a holder having apump receiving portion configured for removably receiving a pump and anoxygenator receiving portion configured for removably receiving anoxygenator; a harness configured to surround at least a portion of apatient's torso, the holder being connected to the harness; and a braceconnected to at least a portion of the harness, the brace configured toextend behind a back portion of a user's head and to support tubingconnected to at least one of the pump and the oxygenator, wherein thebrace has an attachment portion for connecting the brace to the harnessand a support portion extending from the attachment portion forsupporting the tubing.